Elitek

INDICATIONS

Elitek (rasburicase) ® is indicated for the initial management of plasma uric acid levels in pediatric and adult patients with leukemia, lymphoma, and solid tumor malignancies who are receiving anti-cancer therapy expected to result in tumor lysis and subsequent elevation of plasma uric acid.

Limitation of use: Elitek (rasburicase) is indicated only for a single course of treatment
[seeWARNINGS and PRECAUTIONS].

DOSAGE AND ADMINISTRATION

Dosage

The recommended dose of Elitek (rasburicase) is 0.2 mg/kg as a 30 minute intravenous infusion daily for up to 5 days. Dosing beyond 5 days or administration of more than one course is not recommended.

Reconstitution Procedure

Elitek (rasburicase) must be reconstituted with the diluent provided in the carton.

Reconstitute the 1.5 mg vial of Elitek (rasburicase) with 1 mL of diluent. Reconstitute
the 7.5 mg vial of Elitek (rasburicase) with 5 mL of diluent. Mix by swirling gently. Do
not shake or vortex.

Further Dilution and Administration

Do not administer Elitek (rasburicase) as a bolus injection.

Inject the calculated dose of reconstituted Elitek (rasburicase) solution into an infusion
bag containing the appropriate volume of 0.9% sterile sodium chloride, to
achieve a final total volume of 50 mL.

Infuse over 30 minutes through a separate line or flush line with at least
15 mL of normal saline prior to and after Elitek (rasburicase) infusion.

Do not use filters during reconstitution or infusion of Elitek (rasburicase) .